First-ever postpartum depression pill, Zurzuvae, approved by FDA

The Food and Drug Administration on Friday approved the first pill to treat postpartum depression, a condition that data shows affects around 1 in 7 women in the United States.

Health experts say zuranolone, under the brand name Zurzuvae, could be a gamechanger for treating postpartum depression (PPD) and other depressive disorders after clinical trials found the 14-day daily pill began alleviating symptoms in a matter of days.

“Postpartum depression is a serious and potentially life-threatening condition in which women experience sadness, guilt, worthlessness – even, in severe cases, thoughts of harming themselves or their child. And, because postpartum depression can disrupt the maternal-infant bond, it can also have consequences for the child’s physical and emotional development,” said Dr. Tiffany R. Farchione, director of the Division of Psychiatry in the FDA’s Center for Drug Evaluation and Research. “Having access to an oral medication will be a beneficial option for many of these women coping with extreme, and sometimes life-threatening, feelings.”

PPD is a major depressive episode that typically occurs after childbirth but can also begin during the later stages of pregnancy. Until now, treatment for PPD was only available as an IV injection given by a health care provider in certain health care facilities.

“It’s really great that this medication is coming out because if it is able to treat postpartum depression that effectively, then it would alleviate a lot of suffering,” said Dr. Nirmaljit Dhami, medical director of the Inpatient Perinatal Psychiatry Unit at El Camino Health’s Scrivner Center for Mental Health & Addiction Services in Mountain View, California.

Experts also urged researchers to collect more long-term data on zuranolone – as the trial did not follow up with participants past 45 days – and hope its recent approval will shed a light on other drivers of postpartum depression, such as a lack of social support.

“It’s not a magic pill,” said Judite Blanc, assistant professor of psychiatry and behavioral science at the University of Miami Miller School of Medicine. “Social determinants of health are the most impactful cause of postpartum depression.”

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How does the drug work?

Zuranolone is a neuroactive steroid-based antidepressant.

Neuroactive steroids are molecules that naturally occur in the body and are important for managing stress in the brain, said the study’s principal investigator Dr. Kristina Deligiannidis, a professor at the Institute of Behavioral Science at the Feinstein Institutes for Medical Research in New York.

Researchers suggested patients who have postpartum depression may have more brain sensitivity to stress during hormone changes because these molecules don't work properly.

“Although it’s not yet known exactly how zuranolone has rapid antidepressant effects, research suggests that natural neuroactive steroids work to support the brain health by rapidly reducing stress and restoring healthy brain functioning,” Deligiannidis said.

Among the 196 patients who completed the 45-day clinical trial, results published last week in the American Journal of Psychiatry showed that women who took zuranolone saw “statistically significant improvements” by day 15.

The most common side effects reported included drowsiness, dizziness and sedation. But no participants experienced withdrawal symptoms, increased suicidal ideation or behaviors associated with other common antidepressants.

How is this drug different from other antidepressants?

People with postpartum depression are typically treated with a combination of therapy and medications, Dhami said.

The most prescribed medication is a type of antidepressant called selective serotonin reuptake inhibitors, or SSRIs. They ease symptoms of depression by increasing levels of serotonin, which is one of the chemical messengers that carry signals between brain nerve cells, according to the Mayo Clinic.

But Blanc said these SSRIs can take up to 12 weeks to start working.

With zuranolone, the way providers treat postpartum will “necessarily be different,” Deligiannidis said.

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“For many patients, they may only need a short, acute treatment course followed by close monitoring (for any return of depressive symptoms) rather than taking an antidepressant chronically for many months or years,” she said.

But providers say they're still cautious about prescribing zuranolone instead of other antidepressants, especially for patients who have a history of depression.

“What we know and understand about depression in general is that it’s a relapsing and remitting illness,” Dhami said. “One of the things that can guide us and help us in clinical decision making is to follow the patient long-term and see what happens with their symptoms over six months, nine months or one year.”

What typically causes postpartum depression?

Postpartum depression occurs in about 15% of American births, according to the National Institute of Mental Health. There’s no single cause of postpartum depression: The Mayo Clinic says a combination of genetics, physical changes and emotional issues may play a role.

But research has shown social determinants of health and other stressors are also linked to an increased risk of postpartum depression, Blanc said. In addition to clinical therapies, it’s important to address the need for more workplace and social support for expecting parents.

“It’s not just the magic pill but also society, policymakers and workplace. It’s gender role, it’s gender socialization, it’s the idea of motherhood and the strictness in work schedule,” Blanc said.

Symptoms of postpartum depression

According to the Mayo Clinic, symptoms of postpartum depression may include:

• Depressed mood or severe mood swings.

• Crying too much.

• Difficulty bonding with your baby.

• Withdrawing from family and friends.

• Loss of appetite or eating much more than usual.

• Insomnia or sleeping too much.

• Overwhelming tiredness.

• Less interest and pleasure in activities you used to enjoy.

• Intense irritability or anger.

• Hopelessness or feelings of worthlessness, shame, guilt or inadequacy.

• Reduced ability to think clearly, concentrate or make decisions.

• Thoughts of harming yourself or your baby.

• Recurring thoughts of death or suicide.

If you or someone you know may be struggling with suicidal thoughts, dial 988 to reach someone with the Suicide and Crisis Lifeline. They're available 24 hours a day and provide services in multiple languages.

Follow Adrianna Rodriguez on Twitter: @AdriannaUSAT.

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This article originally appeared on USA TODAY: Postpartum depression: FDA approves fast-acting pill Zurzuvae